483
Mid-Continent Packaging, IncMid-Continent Packaging, Inc – FDA 483, Mar 7, 2022
Record Details
An FDA inspection of Mid-Continent Packaging, Inc. in Enid, OK, an OTC drug manufacturer, revealed a significant quality control issue. The firm failed to determine actual and theoretical yield percentages at the conclusion of each manufacturing phase, instead performing these calculations months after product distribution. This practice led to delayed identification of significant yield discrepancies, indicating a breakdown in process control and record-keeping.
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ID · d374b435-7586-4cb3-8e8d-ad12f1695d63
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